JP7520725B2 - 小児患者における発作性夜間ヘモグロビン尿症（ｐｎｈ）の治療のための抗ｃ５抗体の用量および投与 - Google Patents

小児患者における発作性夜間ヘモグロビン尿症（ｐｎｈ）の治療のための抗ｃ５抗体の用量および投与 Download PDF

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JP7520725B2
JP7520725B2 JP2020566282A JP2020566282A JP7520725B2 JP 7520725 B2 JP7520725 B2 JP 7520725B2 JP 2020566282 A JP2020566282 A JP 2020566282A JP 2020566282 A JP2020566282 A JP 2020566282A JP 7520725 B2 JP7520725 B2 JP 7520725B2
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antibody
antigen
binding fragment
dose
composition
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JP2021525718A (ja
JP2021525718A5 (enExample
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ロリ ペイトン，
スコット ティー． ロッティングハウス，
ラジェンドラ プラダーン，
ステファン オルティス，
雅代 小川
シャン ガオ，
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アレクシオン ファーマシューティカルズ， インコーポレイテッド
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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
    • C07K16/283—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily against Fc-receptors, e.g. CD16, CD32, CD64
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/40—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against enzymes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/54—Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/55—Medicinal preparations containing antigens or antibodies characterised by the host/recipient, e.g. newborn with maternal antibodies
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52—Constant or Fc region; Isotype
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565—Complementarity determining region [CDR]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/92—Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Immunology (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Dermatology (AREA)
  • Epidemiology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
JP2020566282A 2018-05-31 2019-05-29 小児患者における発作性夜間ヘモグロビン尿症（ｐｎｈ）の治療のための抗ｃ５抗体の用量および投与 Active JP7520725B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201862678455P 2018-05-31 2018-05-31
US62/678,455 2018-05-31
PCT/US2019/034293 WO2019231983A1 (en) 2018-05-31 2019-05-29 Dosage and administration of anti-c5 antibodies for treatment of paroxysmal nocturnal hemoglobinuria (pnh) in pediatric patients

Publications (3)

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JP2021525718A JP2021525718A (ja) 2021-09-27
JP2021525718A5 JP2021525718A5 (enExample) 2022-05-17
JP7520725B2 true JP7520725B2 (ja) 2024-07-23

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US (1) US12404320B2 (enExample)
EP (1) EP3802593B1 (enExample)
JP (1) JP7520725B2 (enExample)
ES (1) ES2996257T3 (enExample)
WO (1) WO2019231983A1 (enExample)

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CA3024618A1 (en) 2016-05-27 2017-11-30 Alexion Pharmaceuticals, Inc. Methods for treatment of refractory generalized myasthenia gravis
DK3658184T5 (da) 2017-07-27 2024-08-26 Alexion Pharma Inc Højkoncentrerede anti-c5-antistofformuleringer
CN118512588A (zh) 2017-10-26 2024-08-20 亚力兄制药公司 用于治疗阵发性夜间性血红蛋白尿(pnh)和非典型溶血性尿毒症综合征(ahus)的抗c5抗体的剂量和施用
EP3802593B1 (en) 2018-05-31 2024-09-11 Alexion Pharmaceuticals, Inc. Dosage and administration of anti-c5 antibodies for treatment of paroxysmal nocturnal hemoglobinuria (pnh) in pediatric patients
EP3802603A1 (en) 2018-06-04 2021-04-14 Alexion Pharmaceuticals, Inc. Dosage and administration of anti-c5 antibodies for treatment of atypical hemolytic uremic syndrome (ahus) in pediatric patients
US12312394B2 (en) 2018-06-28 2025-05-27 Alexion Pharmaceuticals, Inc. Methods of producing anti-C5 antibodies
EP3873602B1 (en) 2018-10-30 2023-12-06 Alexion Pharmaceuticals, Inc. Subcutaneous dosage and administration of anti-c5 antibodies for treatment of paroxysmal nocturnal hemoglobinuria (pnh)
US20230235035A1 (en) * 2020-07-09 2023-07-27 Alexion Pharmaceuticals, Inc. Dosage and administration of anti-c5 antibodies for treating paroxysmal nocturnal hemoglobinuria (pnh) in pediatric patients

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2017512463A (ja) 2014-03-07 2017-05-25 アレクシオン ファーマシューティカルズ， インコーポレイテッド 向上した薬物動態を有する抗ｃ５抗体
WO2017123636A1 (en) 2016-01-11 2017-07-20 Alexion Pharmaceuticals, Inc. Dosage and administration of anti-c5 antibodies for treatment
JP2021501134A (ja) 2017-10-26 2021-01-14 アレクシオン ファーマシューティカルズ， インコーポレイテッド 発作性夜間ヘモグロビン尿症（ＰＮＨ）および非典型溶血性尿毒症症候群（ａＨＵＳ）の処置のための抗Ｃ５抗体の投薬量および投与

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